Talk track

Key Messages

  • STRATAFIX™ Symmetric PDS™ Plus is paired with premium Ethicon needles that are resistant to bending or breaking, and penetrate tissue smoothly.10
  • It has superior penetration performance, requiring less force, while maintaining strength through dense fascial tissue​.
  • STRATAFIX™ Spiral PDS™ Plus is as strong as V-Loc™ 180 Devices at time zero and provide greater strength retention over time.11-13*†
  • Is the only barbed suture appropriate for high-tension areas, such as fascia.5,14
  • It provides superior tissue-holding strength—39% greater than Coated VICRYL™ Suture and 15% stronger than Medtronic’s V-Loc™ 180 in subcutaneous tissue​​.5
  • It offers extended wound-holding support for up to 6 weeks, compared to 3 weeks with V-Loc™ 180, ensuring the fascia remains securely approximated during the critical healing period​​.13-16‡§
  • Incorporates Plus Antibacterial Technology with triclosan coating, which has been shown in vitro to inhibit E.coli colonization of the suture for 17 days and S. aureus for 23 days.18
  • Aligns with the CDC, ACS/Surgical Infection Society, and NICE guidelines, which recommend triclosan-coated sutures to reduce the risk of SSIs.19-23¶||
  • A meta-analysis of 21 randomized controlled trials showed a 28% reduction in SSI risk with the use of triclosan-coated sutures​.13¶#** 
  • Is more efficient than continuous closure with traditional sutures since there is no need to tie knots or have an assistant follow the suture.25,26

Detailed Talk Track

I noticed the needle in that procedure bent/broke when you were closing the fascia. I’d like to introduce a solution that not only addresses this concern but also provides multiple points of fixation along the suture line for more security, consistency, and efficiency than traditional sutures.1-9 As you have experienced first hand the strength and reliability of the needle is just as important as the needle itself. STRATAFIX™ Symmetric PDS™ Plus is paired with premium Ethicon needles that are resistant to bending or breaking, and penetrate tissue smoothly.10 These needles offer superior penetration performance, requiring less force while maintaining strength through dense fascial tissue. STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are as strong as V-Loc™ 180 Devices at time zero and provide greater strength retention over time.11-13*†

If high tensile strength was mentioned as a need

When closing the fascia, it’s critical to use a suture that offers robust tensile strength to withstand the stress and prevent dehiscence. The STRATAFIX™ Symmetric PDS™ Plus is the only barbed suture specifically designed for high-tension areas like fascia.5,14 It provides superior tissue-holding strength—39% greater than Coated VICRYL™ Suture and 15% stronger than Medtronic’s V-Loc™ 180 in subcutaneous tissue.5 Additionally, it offers extended wound-holding support for up to 6 weeks, compared to 3 weeks with V-Loc™ 180, ensuring the fascia remains securely approximated during the critical healing period.13-16‡§ This long-term strength retention is crucial for preventing complications like wound dehiscence.17

If reducing SSIs is mentioned as important

STRATAFIX™ Symmetric PDS™ Plus incorporates Plus Antibacterial Technology with triclosan coating, which has been shown in vitro to inhibit E.coli colonization of the suture for 17 days and S. aureus for 23 days.18 This technology aligns with the CDC, ACS/Surgical Infection Society, and NICE guidelines, which recommend triclosan-coated sutures to reduce the risk of SSIs.19-23¶|| In fact, a meta-analysis of 21 randomized controlled trials showed a 28% reduction in SSI risk with the use of triclosan-coated sutures.13¶#**

If efficiency is mentioned as important

Closure with STRATAFIX™ Knotless Tissue Control Device is more efficient than continuous closure with traditional sutures since there is no need to tie knots or have an assistant follow the suture.25,26 This is particularly beneficial in robotic surgeries where dexterity can be limited by instrumentation. This can translate into smoother workflows and reduced fatigue during lengthy robotic cases.

References

*In an ex vivo porcine model.

†As demonstrated by 6-week in vitro testing.

‡PDS Plus and PDO. Based on information in the respective IFUs.

§Based on benchtop testing and clinical effect is unknown

¶CDC, WHO, ACS/SIS, NICE, and KRINKO guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.

||All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL™ Plus, VICRYL™ Plus, and PDS™ Plus).

#In a meta-analysis of 21 RCTs, 6462 patients, 95% CI: (14, 40%), P<0.001

**All triclosan-coated sutures in these RCTs were Ethicon Plus Antibacterial Sutures (MONOCRYL™ Plus, VICRYL™ Plus, and PDS™ Plus)

1. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.

2. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.

3. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.

4. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928_01477447-20110714-35.

5. Ethicon, Inc.: 100326296: Time Zero Tissue Holding – Competitive Claims Comparisons for STRATAFIX Knotless Tissue Control Devices vs Various Products. 2015.

6. Ethicon, Inc. Ethicon study AST-2012-0331. Tissue gapping under tension of porcine cadaveric skin incisions closed with Stratafix Spiral in comparison to Monocryl in both interrupted and continuous stitching patterns. Approved on August 24, 2012.

7. Ethicon, Inc. Performance Testing of STRATAFIX SYMMETRIC PDS PLUS Size 0 & 1 Devices – Initiation Strength in Porcine Tissue. AST-2013-0603.

8. Ethicon, Inc. Ethicon Performance Evaluation Memo AST-2012-0510. Performance Testing of STRATAFIX Symmetric Size 2-0 suture device for Tissue Holding Strength with an Incision Defect to Measure Gapping. Dated December 3, 2012.

9. Ethicon, Inc. AST-2013-0056 Performance Testing of STRATAFIX Symmetric PDSSize2-0 suture device for Tissue Holding Strength with Multiple Incision Defects to Measure Gapping

10. Ethicon Wound Closure Manual 2012. Ethicon, Inc.

11. Nonnenmann H. Performance Testing Report for STRATAFIX Spiral PDS Plus – Mechanical Testing. 100491281-Rev 1. November 17, 2016. Ethicon, Inc.

12. Nawrocki J. Report for Assessment of Benchtop Tissue Holding Strength of STRATFIX Spiral PDS PLUS, STRATAFIX Spiral Monocryl PLUS, V-Loc 90 and V-Loc 180 barbed suture devices. 100559286. July 19, 2017. Ethicon, Inc.

13. Nawrocki J. Report for Assessment of Real Time In-Vitro BSR Testing of STRATAFIX Spiral PDS Plus, STRATAFIX Spiral Monocryl PLUS, V-Loc 90 and V-Loc 180 barbed suture devices. 100552029. July 14, 2017. Ethicon, Inc.

14. V-Loc 180 Absorbable Wound Closure Device. Instructions for Use. Medtronic.

15. STRATAFIX™ SPIRAL PDS™ Plus Knotless Tissue Control Device, Antibacterial. Instructions for Use.

16. STRATAFIX™ Spiral PDO Knotless Tissue Control Device Instructions for Use.

17. Sandy-Hodgetts K, Carville K, Leslie GD. Determining risk factors for surgical wound dehiscence: a literature review. Int Wound J. 2015;12(3):265-275. doi:10.1111/iwj.12088

18. Bhende S, Burkley D, Nawrocki J. In vivo and in vitro antibacterial efficacy of absorbable barbed poydioxanone monofilament tissue control device with triclosan. Surg Infect 2018; Volume 19 (4):430-437.

19. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. JAMA Surg. 2017;152(8):784_791.

doi:10.1001_jamasurg. 2017.0904.

20. World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. https:__apps.who.int_iris_bitstream_handle_10665_250680_9789241549882-eng.pdf?sequence=8. Published November 2016. Accessed August 24, 2023

21. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society:

Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2016;224(1):59_74.

22. National Institute for Health and Care Excellence (NICE) Guideline. Surgical site infections: prevention and treatment. NICE website. https:__www.nice.org.uk_guidance_ng125_chapter_Recommendations#closuremethods. Accessed August 24, 2023.

23. Prevention of postoperative wound infections. Recommendation of the Committee for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute. Bundesgesundheitsbl. 2018; 61(4):448_473

24. de Jonge SW, Atema JJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical site infection. Brit J Surg. 2017;ePub-DOI: 10.1002_bjs.10445.

25. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95.

26. Warner JP, Gutowski KA. Abdominoplasty with progressive tension closure using a barbed suture technique. Aesthet Surg J. 2009;29(3):221-225.

CONFIDENTIAL. FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMER OR FOR EXTERNAL DISTRIBUTION.

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